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High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03696654
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
Hospital General Universitario de Guadalajara
Instituto de Investigación Hospital Universitario La Paz
Instituto de Investigaciones del Sueño
Fundación Jiménez Díaz
Hospital General Universitario Santa Lucía
Hospital Universitario de Burgos
Information provided by (Responsible Party):
OlgaMediano, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

Brief Summary:
There are data supporting a possible increase in the prevalence of High Blood Pressure (HBP) in pediatric patients with Sleep Disorder Breathing (SDB). Adeno-tonsillectomy has proven to be an effective treatment in the correction of nocturnal respiratory events in the majority of patients. Our objective is to determine the presence of HBP in pediatric patients with SDB and the impact of adenotonsillar surgery on its correction. Methodology: 286 children (4-18 years old) will be included consecutively referred for suspected SDB. Variables: a) Clinical history; b) Anthropometric variables: weight, height, body mass index, neck, hip and waist perimeter c) Chervin questionnaire d) polysomnography (PSG) for the SDB assessment and e) for the HBP evaluation, ambulatory blood pressure measurement (ABPM) and pulse transit time (PTT) will be performed during 24h. In control group (not SDB) and patients with indication for medical treatment, the same tests will be repeated six months after the baseline visit. In patients with surgery indication, ABPM and PTT will be performed just before the surgical treatment and ABPM, PTT and PSG six months after the intervention. In a subgroup of patients, will also assess the presence of subclinical organic damage produced by HBP: blood markers (creatinine / glomerular filtration), urine (albuminuria / proteinuria), electrocardiogram and echocardiography (left ventricle hypertrophy).

Condition or disease Intervention/treatment Phase
Blood Pressure Sleep Disorder; Breathing-Related Procedure: adenotonsillar surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The control system of measurements will be before and after treatment on the same group of patients (children with SDB and indication for adeno-tonsillectomy). For the analysis of the main variable (mean systolic blood pressure-BP), baseline values will be obtained through ambulatory blood pressure monitoring (ABPM) and pulse transit time (PTT) in the basal visit. In order to evaluate the impact of treatment of SDB (adeno-tonsillar surgery) on BP, the measurement will be repeated just before the surgical intervention (ABPM and PTT) and six months after surgery (ABPM and PTT) in the same group. In this way, a control group will be available (measurements just before the surgery / control group) that will be compared with the measurements of those same patients six months after the surgery (treatment group). This measure allows having control values without preventing the treatment of any patient and without causing delays in the application of the same linked to the study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
No Intervention: Before treatment
Active Comparator: After treatment Procedure: adenotonsillar surgery
when indicated, adenotonsillar surgery for SDB treatment




Primary Outcome Measures :
  1. Mean systolic blood pressure [ Time Frame: 6 months ]
    Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment


Secondary Outcome Measures :
  1. Apnea hypopnea index [ Time Frame: 6 months ]
    Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).

  2. Percentage of change of mean systolic blood pressure between day and night [ Time Frame: 6 months ]
    To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB

  3. blood pressure in clinic [ Time Frame: 6 months ]
    Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).

  4. creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy. [ Time Frame: 6 months ]
    Assess the manifestation of subclinical organic damage by means of other markers such as: blood (creatinine / glomerular filtration), urine (albuminuria / proteinuria) and echocardiography (left ventricle hypertrophy).

  5. Pulse transit time [ Time Frame: 6 months ]
    Validate the pulse transit time (PTT) measurement as arterial pressure monitoring.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Approval of the Ethics and Clinical Trials Committee
  • Informed consent signed by the parents and / or guardians
  • Children from 4 to 18 years old assessed consecutively due to SDB suspicion.

Exclusion Criteria:

  • Associated comorbidities: Cardiovascular (including cardiac malformation), cerebrovascular or severe unstable respiratory disease that makes it impossible to complete the studies
  • Genetic diseases
  • Children with chronic insomnia and / or depressive syndrome
  • Children with malformation syndromes (including craniofacial malformations), Down syndrome, and neuromuscular diseases
  • Previous otorhinolaryngologic surgery and / or CPAP treatment
  • Contraindication for the realization of the ABPM / PTT (arrhythmias, latex allergy or coagulation disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696654


Contacts
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Contact: Olga Mediano, MD +34 678634778 olgamediano@hotmail.com

Locations
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Spain
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Spain, 19002
Contact: Olga Mediano, MD         
Sponsors and Collaborators
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
Hospital General Universitario de Guadalajara
Instituto de Investigación Hospital Universitario La Paz
Instituto de Investigaciones del Sueño
Fundación Jiménez Díaz
Hospital General Universitario Santa Lucía
Hospital Universitario de Burgos

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Responsible Party: OlgaMediano, Principal Investigator, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
ClinicalTrials.gov Identifier: NCT03696654    
Other Study ID Numbers: adm00064
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Wake Disorders
Parasomnias
Hypertension
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Vascular Diseases
Cardiovascular Diseases